Product profile · United States
ALYFTREK
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2039. Anchor type: PATENT. Patent anchor: 2039-02-14. Exclusivity anchor: 2031-12-20. Anchor date: 2039-02-14. Patent tail: yes. Exclusivity tail: no. Review status: FINAL. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8354427 | 2026-07-06 | U U-4091 | N | N | U English description not available. | — | — | — |
| 8354427 | 2026-07-06 | ORANGE_BOOK U-4091 | N | N | U English description not available. | — | — | — |
| 8410274 | 2026-12-28 | DP — | N | N | DP English description not available. | — | — | — |
| 8410274 | 2026-12-28 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 8754224 | 2026-12-28 | DS/DP — | N | N | DP English description not available. | — | — | — |
| 8754224 | 2026-12-28 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 9670163 | 2026-12-28 | DP/U U-4080 | N | N | DP English description not available. | — | — | — |
| 9670163 | 2026-12-28 | DP/U U-4470 | N | N | DP English description not available. | — | — | — |
| 9670163 | 2026-12-28 | ORANGE_BOOK U-4080;U-4470 | N | N | DP English description not available. | — | — | — |
| 9931334 | 2026-12-28 | DP/U U-4080 | N | N | U English description not available. | — | — | — |
| 9931334 | 2026-12-28 | DP/U U-4469 | N | N | U English description not available. | — | — | — |
| 9931334 | 2026-12-28 | ORANGE_BOOK U-4080;U-4469 | N | N | U English description not available. | — | — | — |
| 10022352 | 2027-04-09 | DP/U U-4081 | N | N | U English description not available. | — | — | — |
| 10022352 | 2027-04-09 | ORANGE_BOOK U-4081 | N | N | U English description not available. | — | — | — |
| 10239867 | 2027-04-09 | DS/DP/U U-4090 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10239867 | 2027-04-09 | DS/DP/U U-4464 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10239867 | 2027-04-09 | ORANGE_BOOK U-4090;U-4464 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11639347 | 2027-04-09 | DS/DP/U U-4464 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11639347 | 2027-04-09 | DS/DP/U U-4090 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11639347 | 2027-04-09 | ORANGE_BOOK U-4090;U-4464 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9974781 | 2027-04-09 | DP/U U-4463 | N | Y | U English description not available. | — | — | — |
| 9974781 | 2027-04-09 | DP/U U-4082 | N | Y | U English description not available. | — | — | — |
| 9974781 | 2027-04-09 | ORANGE_BOOK U-4082;U-4463 | N | Y | U English description not available. | — | — | — |
| 7645789 | 2027-05-01 | DS/DP — | N | N | TRUE_DS English description not available. | — | — | — |
| 7645789 | 2027-05-01 | ORANGE_BOOK — | N | N | TRUE_DS English description not available. | — | — | — |
| 8598181 | 2027-05-01 | U U-4090 | N | N | U English description not available. | — | — | — |
| 8598181 | 2027-05-01 | U U-4463 | N | N | U English description not available. | — | — | — |
| 8598181 | 2027-05-01 | ORANGE_BOOK U-4090;U-4463 | N | N | U English description not available. | — | — | — |
| 8623905 | 2027-05-01 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 8623905 | 2027-05-01 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 7495103 | 2027-05-20 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 7495103 | 2027-05-20 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 7776905 | 2027-06-03 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 7776905 | 2027-06-03 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 8324242 | 2027-08-05 | U U-4464 | N | N | U English description not available. | — | — | — |
| 8324242 | 2027-08-05 | U U-4090 | N | N | U English description not available. | — | — | — |
| 8324242 | 2027-08-05 | ORANGE_BOOK U-4090;U-4464 | N | N | U English description not available. | — | — | — |
| 8415387 | 2027-11-12 | U U-4082 | N | Y | U English description not available. | — | — | — |
| 8415387 | 2027-11-12 | U U-4463 | N | Y | U English description not available. | — | — | — |
| 8415387 | 2027-11-12 | ORANGE_BOOK U-4082;U-4463 | N | Y | U English description not available. | — | — | — |
| 10646481 | 2029-08-13 | DP — | N | N | DP English description not available. | — | — | — |
| 10646481 | 2029-08-13 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11564916 | 2029-08-13 | U U-4466 | N | N | U English description not available. | — | — | — |
| 11564916 | 2029-08-13 | U U-4095 | N | N | U English description not available. | — | — | — |
| 11564916 | 2029-08-13 | ORANGE_BOOK U-4095;U-4466 | N | N | U English description not available. | — | — | — |
| 10081621 | 2031-03-25 | DP/U U-4087 | N | N | DP English description not available. | — | — | — |
| 10081621 | 2031-03-25 | DP/U U-4468 | N | N | DP English description not available. | — | — | — |
| 10081621 | 2031-03-25 | ORANGE_BOOK U-4087;U-4468 | N | N | DP English description not available. | — | — | — |
| 11578062 | 2031-03-25 | DP/U U-4096 | N | N | DP English description not available. | — | — | — |
| 11578062 | 2031-03-25 | DP/U U-4465 | N | N | DP English description not available. | — | — | — |
| 11578062 | 2031-03-25 | ORANGE_BOOK U-4096;U-4465 | N | N | DP English description not available. | — | — | — |
| RE50453 | 2031-07-10 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| RE50453 | 2031-07-10 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 10047053 | 2032-05-17 | DS — | N | N | PROCESS English description not available. | — | — | — |
| 10047053 | 2032-05-17 | ORANGE_BOOK — | N | N | PROCESS English description not available. | — | — | — |
| 8865902 | 2032-05-17 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 8865902 | 2032-05-17 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 9181192 | 2032-05-17 | DS/DP/U U-4472 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9181192 | 2032-05-17 | DS/DP/U U-4094 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9181192 | 2032-05-17 | ORANGE_BOOK U-4094;U-4472 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9512079 | 2032-05-17 | DS/DP/U U-4098 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9512079 | 2032-05-17 | DS/DP/U U-4471 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9512079 | 2032-05-17 | ORANGE_BOOK U-4098;U-4471 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10058546 | 2033-07-15 | U U-4218 | N | N | U English description not available. | — | — | — |
| 10058546 | 2033-07-15 | ORANGE_BOOK U-4218 | N | N | U English description not available. | — | — | — |
| 9012496 | 2033-07-15 | U U-4097 | N | N | U English description not available. | — | — | — |
| 9012496 | 2033-07-15 | ORANGE_BOOK U-4097 | N | N | U English description not available. | — | — | — |
| 10206877 | 2035-04-14 | DP/U U-4467 | N | N | DP English description not available. | — | — | — |
| 10206877 | 2035-04-14 | DP/U U-4092 | N | N | DP English description not available. | — | — | — |
| 10206877 | 2035-04-14 | ORANGE_BOOK U-4092;U-4467 | N | N | DP English description not available. | — | — | — |
| 11951212 | 2035-04-14 | DP/U U-4461 | N | N | DP English description not available. | — | — | — |
| 11951212 | 2035-04-14 | DP/U U-4089 | N | N | DP English description not available. | — | — | — |
| 11951212 | 2035-04-14 | ORANGE_BOOK U-4089;U-4461 | N | N | DP English description not available. | — | — | — |
| 11066417 | 2039-02-14 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 11066417 | 2039-02-14 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 11866450 | 2039-02-14 | U U-4463 | N | Y | U English description not available. | — | — | — |
| 11866450 | 2039-02-14 | U U-4082 | N | Y | U English description not available. | — | — | — |
| 11866450 | 2039-02-14 | ORANGE_BOOK U-4082;U-4463 | N | Y | U English description not available. | — | — | — |
| 11873300 | 2040-08-13 | DS/DP/U U-4083 | N | N | DP English description not available. | — | — | — |
| 11873300 | 2040-08-13 | DS/DP/U U-4462 | N | N | DP English description not available. | — | — | — |
| 11873300 | 2040-08-13 | ORANGE_BOOK U-4083;U-4462 | N | N | DP English description not available. | — | — | — |
| 12186306 | 2043-01-10 | U U-4460 | N | N | U English description not available. | — | — | — |
| 12186306 | 2043-01-10 | U U-4088 | N | N | U English description not available. | — | — | — |
| 12186306 | 2043-01-10 | ORANGE_BOOK U-4088;U-4460 | N | N | U English description not available. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2024-12-20 | 2029-12-20 | English description not available. | Y | Y | 2029-12-20 | — | Source |
| NCE | 2024-12-20 | 2029-12-20 | English description not available. | Y | Y | 2029-12-20 | ODE-526 + ODE-536
Full coverage date: 2029-12-20
| Source |
| ODE-526 | 2024-12-20 | 2031-12-20 | English description not available. | N | N | — | — | Source |
| ODE-526 | 2024-12-20 | 2031-12-20 | English description not available. | N | N | — | ODE-526 + ODE-536
Full coverage date: —
| Source |
| ODE-536 | 2026-03-27 | 2033-03-27 | English description not available. | N | N | — | — | Source |
| ODE-536 | 2026-03-27 | 2033-03-27 | English description not available. | N | N | — | ODE-526 + ODE-536
Full coverage date: —
| Source |
2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE
Generic approval evidence
| Application / product | Event | Final date | Tentative date | Applicant | Authorized generic | Exact mapping | Source |
|---|---|---|---|---|---|---|---|
| No generic approval facts are linked to this product. | |||||||
Market Entry Information
API filings, authorized generics and linked regulatory milestones.
API Master Files & Certifications 0 records
Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.
| API | Holder / manufacturer | Holder country | Filing type | Number | Status | Filed date | Available for reference | Source | Last verified |
|---|---|---|---|---|---|---|---|---|---|
| No master-file or certification records are linked through public manufacturer portfolios. | |||||||||
Authorized Generics 0 records
Authorized generics are shown separately from independent ANDA approvals.
| Application / product | Applicant | Event / status | First marketed | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No authorized-generic records are linked to this product. | ||||||
Tentative ANDA Approvals 0 records
Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.
| Application / product | Applicant | Event / status | Tentative date | Follow-up final approval | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|---|
| No tentative-approval records are linked to this product. | |||||||
Paragraph IV Challenges 0 records
Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.
| Application / product | Applicant | Event / status | Certification event date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No structured Paragraph IV certification events are linked in the available approval evidence. | ||||||
Final ANDA Approvals 0 records
Approval dates do not establish commercial launch. Product mapping is shown for each linked record.
| Application / product | Applicant | Event / status | Final approval date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No final-approval records are linked to this product. | ||||||
Decision evidence (37)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2026-07-06 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2026-12-28 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2026-12-28 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2026-12-28 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2026-12-28 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-04-09 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-04-09 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-04-09 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-04-09 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-05-01 | NOT_APPLICABLE_TO_EXACT_PRODUCT | English description not available. | Source |
| PATENT | 2027-05-01 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-05-01 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-05-20 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-06-03 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-08-05 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-11-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2029-08-13 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2029-08-13 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-03-25 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-03-25 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-07-10 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2032-05-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2032-05-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2032-05-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2032-05-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-07-15 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-07-15 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-04-14 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-04-14 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2039-02-14 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2039-02-14 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2040-08-13 | FTO_TAIL | English description not available. | Source |
| PATENT | 2043-01-10 | FTO_TAIL | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_STATUS | 2039-02-14 | CANONICAL_DECISION | English description not available. | Source |
Independent legal-event information
Litigation & Settlement History
Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.
No litigation or settlement record currently linked to this product.